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The Use of VSL#3 in Irritable Bowel Syndrome in Children

This study has been terminated.
(PI has re-located. PI terminated FDA IND # and closed study.)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sonia Michail, MD, Children's Medical Center of Dayton
ClinicalTrials.gov Identifier:
NCT00932841
First received: July 2, 2009
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.


Condition Intervention Phase
Irritable Bowel Syndrome
 Other: Placebo
Drug: VSL#3 900 billion bacteria
Drug: VSL#3 90 billion bacteria
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of VSL#3 in Irritable Bowel Syndrome in Children

Further study details as provided by Children's Medical Center of Dayton:

Primary Outcome Measures:
  • The Gastrointestinal Symptom Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Coddington life events questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
One packet PO daily x 8 weeks.
Other Name: VSL#3
Active Comparator: VSL#3 90 billion bacteria Drug: VSL#3 90 billion bacteria
One packet PO daily, x 8 weeks.
Other Name: VSL#3
Active Comparator: VSL#3 900 billion bacteria Drug: VSL#3 900 billion bacteria
One packet PO daily, x 8 weeks
Other Name: VSL#3

Detailed Description:

Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children should fulfill Rome ll criteria for IBS.
  • Organic disease has been excluded.
  • Age 13-18 years.
  • Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
  • Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.

Exclusion Criteria:

  • Children not fulfilling the inclusion criteria.
  • Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
  • Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
  • Children receiving other medication known to cause abdominal pain.
  • Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
  • Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
  • Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
  • Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
  • Children with a history of malignancy.
  • Pregnancy.
  • Children with history of allergy to maize or probiotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932841

Locations
United States, Ohio
Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
Sponsors and Collaborators
Children's Medical Center of Dayton
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sonia Michail, MD Wright State University, Children's Medical Center of Dayton
  More Information

Publications:

Responsible Party: Sonia Michail, MD, Principal Investigator, Children's Medical Center of Dayton
ClinicalTrials.gov Identifier: NCT00932841     History of Changes
Other Study ID Numbers: 04-007, R21AT003400-01A2
Study First Received: July 2, 2009
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013